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At least 127 records · Page 7Linked to original sources

Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: the Eastern Cooperative Oncology Group (ECOG) results of protocol E1293.

The aim of this study was to evaluate the clinical efficacy and safety of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy. Docetaxel 100 mg m-2 was administered as a 1 hour intravenous (IV) infusion every 3 weeks to 41 patients. Patients were premedicated prior to each course with dexamethasone, diphenhydramine and cimetidine. Clinical response and toxicity were determined. Objective responses were seen in seven of 41 eligible patients (two complete responses [CRs] and five partial responses [PRs], for an objective response rate of 17% (90% confidence interval [CI], 8% to 30%). The most common toxicity was grade 4 neutropenia, which occurred in 88% of patients; 46% of patients required a dose reduction following an episode of neutropenic fever requiring antibiotic therapy. Additional patients have had reversible grade 3-4 toxicities including nausea, vomiting, stomatitis, diarrhea, fatigue and peripheral neuropathy. Ten patients have had grade 1-3 hypersensitivity reactions. Alopecia has been seen in the majority of patients. Fluid retention grade 1-3 has been observed in patients. Docetaxel administered on this schedule is an active agent in adenocarcinomas of the upper gastrointestinal tract. Further investigation of this drug should be conducted in multi-drug combination programs.

Adenocarcinoma↗

Suppression of cortical epileptiform activity by generalized and localized ECoG desynchronization.

The effects of high frequency electrical stimulation of both diffusely projecting brain regions and regions of more restricted projection were studied on penicillin-induced cortical epileptiform focal activity in the cat. Results obtained were contingent on the level of focal activity present at the time of stimulation. Very active foci (spike rates above 0.5/sec) were uniformly driven by stimulation of all structures under study. Foci exhibiting weak to moderate levels of activity were, on the other hand, inhibited both during and following stimulation. Episodes of spike suppression induced through stimulation of diffusely projecting structures were typically followed by an intensified "rebound" of interictal activity. Episodes of suppression induced through stimulation of regions of limited projection were not followed by such rebounds, an effect most dramatically apparent with caudate stimulation and motor cortex foci. Results are discussed in terms of the interaction between naturally occurring brain rhythms in sleep and arousal with the epileptic process.

Animals↗

Adrenal cortical carcinoma: flow cytometric study of 22 cases, an ECOG study.

Flow cytometric studies of archival material from 22 adrenal carcinomas demonstrated aneuploidy in 21 of 22 cases. Heterogeneity of nuclear DNA was found in 14 of the 22 cases. Eight of these showed distinct aneuploid and diploid populations, and 6 showed multiple aneuploid cell lines. The heterogeneity was detected because numerous paraffin-embedded samples of each tumor could be examined. No correlation was found between either aneuploidy or heterogeneous DNA content and patient survival, response to therapy, or hormone secretion.

Adrenal Cortex Neoplasms↗

Event-related desynchronization and movement-related cortical potentials on the ECoG and EEG.

Event-related desynchronization (ERD) 2.0 sec before and 1.0 sec after movement in the frequency bands of 8-10, 10-12, 12-20 and 20-30 Hz and movement-related cortical potentials (MRCPs) to self-paced movements were studied from subdural recordings over the central region in 3 patients, and from scalp-recorded EEGs in 20 normal volunteers. In direct cortical recordings, the peak ERD response and peak MRCP amplitude to self-paced finger movements were maximal over recording sites in the contralateral hand motor representations. The topography and time of onset of the ERD response to finger and foot movements suggest that the ERD responses in the 8-10 Hz and 10-12 Hz bands are more somatotopically restricted than the responses in the higher frequency bands. The power recovery and subsequent overshoot in the different frequency bands occurred in an orderly fashion with the faster frequencies recovering earlier. The ERD responses on the scalp-recorded EEGs were of lower magnitude and more widely distributed than those occurring on the subdural recordings. Across the population, there was no relation between the magnitude of the ERD response in any of the frequency bands studied and the peak amplitude of the negative slope (pNS') and the frontal peak of the motor potential (fpMP) of the MRCPs. MRCPs and ERD responses originate in similar cortical regions and share some common timing features, but the magnitude and spatial distribution of the two responses appear to be independent of each other, which suggests that the physiological mechanisms governing these two events are different and may represent different aspects of motor cortex activation. Differences in the timing and topographical features of the ERD responses in the various frequency bands also suggest a distinct functional significance for the various spectral components of the electrical activity in the motor cortex.

Adult↗

Combined modality treatment of regional small cell undifferentiated carcinoma of the lung: a cooperative study of the RTOG and ECOG.

Between 1975 and 1979, 271 patients with regional small cell undifferentiated (including oat cell) carcinoma of the lung were entered into a study involving treatment by radiation therapy (4500 cGy (rad) in five weeks) to the primary tumor, mediastinum and supraclavicular lymph nodes, and a randomization to receive or not receive prophylactic treatment of the brain (3000 cGy in two weeks) and a randomization to prophylactic or delayed chemotherapy (cyclophosphamide and CCNU). Analysis of the data indicates that the median survival for responders (53 weeks) was significantly longer than that of the non-responders and partial responders (37 and 34 weeks). Median survival by treatment arm was 48 weeks for thoracic irradiation (TI), brain irradiation (BI), and early chemotherapy (CT), 44 weeks for TI alone, 41 weeks for TI and CT, 38 weeks for TI and BI. Regional complete and partial tumor responses were 52 and 25% for prophylactic chemotherapy and 44 and 35% for delayed chemotherapy. The site of first failure was regional in 12%, regional and distant simultaneously in 21%, and distant only in 46%. Elective brain irradiation significantly reduced the incidence of brain metastases from 21 and 5%, but did not improve survival.

Brain Neoplasms↗

Unifying and interpreting the spectral wavenumber content of EEGs, ECoGs, and ERPs.

A biological model of corticothalamic dynamics is used to investigate the spatial power spectrum (wavenumber spectrum) of electrical activity in the brain. The model provides a single framework for unifying different aspects of activity. Comparisons of the predicted spectra with published electrocorticographic, electroencephalographic, and evoked response potential data enable physiology and anatomy to be inferred, producing results which are complementary to those obtained from comparisons in the frequency domain; the inferred quantities are consistent with, and complementary to, direct physiological and anatomical measurements. We also use the model to quantify the interdependence of the wavenumber and frequency domains, and deduce that further experiments that cover large wavenumber and frequency ranges simultaneously would greatly increase our knowledge of brain function. We conclude that both the frequency and wavenumber domains should be studied in order to build the fullest picture of brain dynamics: the two domains are both complementary and interdependent.

Brain↗

Phase II trial of subcutaneous recombinant human interleukin 11 with subcutaneous recombinant human granulocyte-macrophage colony stimulating factor in patients with acute myeloid leukemia (AML) receiving high-dose cytarabine during induction: ECOG 3997.

Randomized trials of substituting high-dose cytarabine (HiDAC) for standard dose cytarabine (SDAC) during induction therapy for newly diagnosed AML have not demonstrated an improvement in the complete remission (CR) rate. Phase II trials of the scheduled administration of HiDAC after SDAC suggest an improved outcome. The hematological complications of intensification are considerable. GM-CSF after chemotherapy improved the survival of older patients in a randomized trial. Recombinant human interleukin 11, a thrombopoietic cytokine, reduced the incidence of chemotherapy-induced thrombocytopenia in patients with solid tumors. Therefore, 34 patients were treated, with newly diagnosed AML less than 56 years of age, with daunorubicin 45 mg/m2 on days 1-3, cytarabine 100mg/m2 days 1-7 and cytarabine 2g/m2 for 12 h on days 8-10 (7+3+3). rhIL-11 (50 microg/kg/day,) and GM-CSF (250 microg/kg/day) were administered subcutaneously from day 11 until recovery. The complete remission rate was 59% (90% C.I. 43-73%). The median time to recovery of neutrophils to >500 and platelets to > or =20,000 microl(-1) was 27 days (95% C.I. 27-30 days) and 25 days (95% C.I. 24-29 days), respectively. The trial does not confirm the high CR rate observed in phase II trials, despite optimal supportive care.

Acute Disease↗

Post-operative radiotherapy (PORT) or chemoradiotherapy (CPORT) following resection of stages II and IIIA non-small cell lung cancer (NSCLC) does not increase the expected risk of death from intercurrent disease (DID) in Eastern Cooperative Oncology Group (ECOG) trial E3590.

To determine the influence of adjuvant therapy on the risk of DID following resection of NSCLC, we compared the actuarial rate of non-cancer related deaths of patients who had been entered in Eastern Cooperative Oncology Group E3590 (a phase III trial of adjuvant therapy in patients with completely resected stages II and IIIA NSCLC) to the actuarial death rate of age and gender matched controls. Following surgery, patients were randomized to receive either PORT (5040 cGy in 28 daily fractions) or CPORT (PORT plus four cycles of cisplatin (60 mg/m2, day 1) and etoposide (120 mg/m2, days 1-3) administered concurrently). The study accrued 488 patients, 242 to the PORT only arm and 246 to the CPORT arm. The overall 4 years actuarial rate of DID for the two arms combined, with a median follow-up of 82 months, was 12.9%, not significantly different from the 10.1% expected rate of DID, based on mortality rates for age and gender matched controls derived from US vital statistics and corrected for smoking status (p=0.16). Survival distributions with regard to DID did not differ between the two treatment arms (p=0.96). DID increased with age (treated as a continuous variable, p<0.01), but was not affected by histology, side of chest irradiated, type of surgery, FEV1 or weight loss in the previous 6 months. The risk of DID following resection of stages II and IIIA NSCLC is not increased in patients who received PORT or CPORT.

Age Factors↗